Advanced Non-squamous Non-small-cell Lung CancerPhase 2XQonc-007NCT03190239
Efficacy and Safety of Maintenance Apatinib Combined With Pemetrexed in Advanced Non-squamous Non-small Cell Lung Cancer Patients
A Phase 2 study testing Apatinib and Pemetrexed in people with Advanced Non-squamous Non-small-cell Lung Cancer, run by Xinqiao Hospital of Chongqing at 1 site in China.
Trial summary
Lung cancer is a malignant tumor that causes the highest morbidity and mortality, and the main pathological type is non-small cell lung cancer (NSCLC). Most of them present with advanced stage at diagnosis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Non-squamous Non-small-cell Lung Cancer
- What is being tested?
- Apatinib and Pemetrexed
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 15 Jul 2017to 30 Jul 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologic confirmed，locally advanced and/or metastatic non-squamous NSCLC of stage IIIB or IV or recurrent NSCLC
- At least one measurable lesion
- If genetic testing (EGFR/ALK) is a sensitive EGFR mutation or ALK fusion gene positive, required for first line progress after targeted therapy;Without mutations, required for first-line treatment;
- Pemetrexed combined platinum did not progress by RECIST curative effect evaluation after 4 cycles of chemotherapy
- ≥ 18 years of age ,Male or female
- Eastern Cooperative Oncology Group(ECOG)performance scale 0 - 2.
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- Life expectancy of more than 3 weeks.
- Adequate hepatic, renal, heart, and hematologic functions (Absolute Neutrophil Count(ANC) ≥ 1.5×109/L, Platelet (PLT) ≥ 100×109/L, Hemoglobin(HB) ≥ 100 g/L, total bilirubin within 1.5×the upper limit of normal(ULN), and serum transaminase≤2.5×the Upper Limit Of Normal(ULN), serum creatine ≤ 1 x Upper Limit Of Normal(ULN), creatinine clearance rate ≥ 50ml/min,
- For women of child-bearing age, the pregnancy test results (serum or urine) within 7 days before enrolment must be negative. They will take appropriate methods for contraception during the study until the 8th week post the last administration of study drug. For men (previous surgical sterilization accepted), will take appropriate methods for contraception during the study until the 8th week post the last administration of study drug.
- Signed and dated informed consent. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure.
Who cannot join
- Squamous cell carcinoma (including adenosquamous carcinoma, undifferentiated carcinoma); small cell lung cancer (including small cell and non-small cell mixed lung cancer)
- Genetic testing for sensitive EGFR mutation or ALK fusion gene is positive didn't accept targeted therapy
- Symptomatic brain metastases (Patients who have no symptoms and is not needed to receive therapy before 21 days may participate in this trial, but need to be confirmed by MRI\CT or venography that no hematencephalon symptom);
- Imaging (CT or MRI) shows that the tumor lesion vessels≤ 5 mm, or in the center of the large vessels tumor;Or show obvious lung empty or necrotic tumor;
- Uncontrolled hypertension(systolic pressure ≥ 140 mmHg and/or diastolic pressure ≥ 90 mm Hg) even though two or more than two hypotensive agents application.
- Patients who suffered from grade II or above myocardial ischemia or myocardial infarction, uncontrolled arrhythmias (including QT interval male ≥ 450 ms, female ≥ 470 ms). Grade III-IV cardiac insufficiency according to New York Heart Association(NYHA) criteria or echocardiography check: left ventricular ejection fraction (LVEF)<50%.
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- History of pulmonary interstitial diseases or concurrent pulmonary interstitial diseases.
- Coagulation disfunction（INR>1.5 o rPT>Upper Limit Of Normal(ULN)+4s or Activated Partial Thromboplastin Time (APTT) >1.5 Upper Limit Of Normal(ULN)）, hemorrhagic tendency or receiving the therapy of thrombolysis or anticoagulation.
- History of clinically significant haemoptysis =< 2 months (more than 2.5ml or half of one tea spoon of fresh blood per day) prior to registration.
- History of clinically relevant major bleeding event=< 3 months.
- Within 12 months before the first treatment occurs artery / venous thromboembolic events, such as cerebral vascular accident (including transient ischemic attack(TIA), hematencephalon, cerebral infarction), deep vein thrombosis and pulmonary embolism, etc.
- Known inherited and acquired hemorrhagic and thromboplastic possibility (such as hemophilia, coagulopathy, thrombocytopenia, hypersplenism, etc.)
- Long-term untreated wounds or fractures.
- Within 4 weeks of major surgery and/or injures, fractures , ulceration.
- Significant factors that influence the ingestion and absorption of medicine, (e.g. unable swallow, chronic diarrhea and intestinal obstruction).
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess ≤ 6 months.
- Urine protein≥++, or 24h urine protein quantitation≥1.0g.
- History of psychiatric drugs abuse and not be abstinent, or dysphrenia.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Maintenance Apatinib Combined With Pemetrexed After First - Line Induction Chemotherapy in Advanced Non-squamous Non-small Cell Lung Cancer: A Prospective, Open, Single Arm Clinical Study
Lung cancer is a malignant tumor that causes the highest morbidity and mortality, and the main pathological type is non-small cell lung cancer (NSCLC). Most of them present with advanced stage at diagnosis. This design is to study maintenance therapy with pemetrexed plus apatinib after first line induction therapy four cycles for advanced non-squamous non-small-cell lung cancer. XQonc-0007
Read the detailed description
XQonc-0007
- Being tested
- Apatinib, Pemetrexed
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApatinibDrug
Apatinib 250mg qd
PemetrexedDrug
Pemetrexed 500mg/m2 qm
| Study group | Role | What they receive |
|---|---|---|
| Apatinib XQonc-0007 | Experimental | Pemetrexed 500 mg/m2, qm; Apatinib 250 mg Po qd Receives: Drug: Apatinib; Drug: Pemetrexed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival（PFS）
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to two years
Measured: Up to two years
Secondary outcomes (4)
Overall survival (OS)
From date of randomization until the date of death from any cause, assessed up to three years
Measured: Up to three years
Objective response rate
ORR is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response as best overall response according to radiological assessments.
Measured: Up to two years
Disease control rate
Investigators will assess treatment response according to Response Evaluation Criteria in Solid Tumors 1.1（RECIST1.1）
Measured: Up to two years
Adverse Events
AEs are evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events v4.0.
Measured: Up to two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2017
- Study start15 Jul 2017 (estimated)
- Primary completion30 Jul 2020 (estimated)
- Study completion30 Jul 2020 (estimated)
Why it stopped: abandon
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Non-squamous Non-small-cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xinqiao Hospital of Chongqing
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianguo Sun, Xinqiao Hospital of Chongqing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03190239
- Sponsor's protocol ID
- XQonc-007
- Acronym
- XQonc-007
- Status last verified
- Feb 2024
- First submitted
- 12 May 2017
- Last updated
- 28 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Maintenance Apatinib Combined With Pemetrexed After First - Line Induction Chemotherapy in Advanced Non-squamous Non-small Cell Lung Cancer: A Prospective, Open, Single Arm Clinical Study
- ClinicalTrials.gov ID
- NCT03190239
- Acronym / sponsor ID
- XQonc-007 / XQonc-007
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: abandon
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Xinqiao Hospital of ChongqingUniversity, hospital or other
- Study start
- 15 Jul 2017 (estimated)
- Primary completion
- 30 Jul 2020 (estimated)
- Study completion
- 30 Jul 2020 (estimated)
- First posted
- 16 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Lung cancer is a malignant tumor that causes the highest morbidity and mortality, and the main pathological type is non-small cell lung cancer (NSCLC). Most of them present with advanced stage at diagnosis. This design is to study maintenance therapy with pemetrexed plus apatinib after first line induction therapy four cycles for advanced non-squamous non-small-cell lung cancer. XQonc-0007
Detailed description
XQonc-0007
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Apatinib XQonc-0007 | Experimental | Drug: Apatinib, Drug: PemetrexedPemetrexed 500 mg/m2, qm; Apatinib 250 mg Po qd |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Histologically or cytologic confirmed，locally advanced and/or metastatic non-squamous NSCLC of stage IIIB or IV or recurrent NSCLC
- At least one measurable lesion
- If genetic testing (EGFR/ALK) is a sensitive EGFR mutation or ALK fusion gene positive, required for first line progress after targeted therapy;Without mutations, required for first-line treatment;
- Pemetrexed combined platinum did not progress by RECIST curative effect evaluation after 4 cycles of chemotherapy
- ≥ 18 years of age ,Male or female
Key exclusion criteria (18 listed)
- Squamous cell carcinoma (including adenosquamous carcinoma, undifferentiated carcinoma); small cell lung cancer (including small cell and non-small cell mixed lung cancer)
- Genetic testing for sensitive EGFR mutation or ALK fusion gene is positive didn't accept targeted therapy
- Symptomatic brain metastases (Patients who have no symptoms and is not needed to receive therapy before 21 days may participate in this trial, but need to be confirmed by MRI\CT or venography that no hematencephalon symptom);
- Imaging (CT or MRI) shows that the tumor lesion vessels≤ 5 mm, or in the center of the large vessels tumor;Or show obvious lung empty or necrotic tumor;
- Uncontrolled hypertension(systolic pressure ≥ 140 mmHg and/or diastolic pressure ≥ 90 mm Hg) even though two or more than two hypotensive agents application.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ApatinibApatinib 250mg qd | Drug | Apatinib XQonc-0007 |
| PemetrexedPemetrexed 500mg/m2 qm | Drug | Apatinib XQonc-0007 |
Primary outcome
Progression free survival（PFS）
Time frame: Up to two years
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to two years
4 secondary outcomes
Overall survival (OS)
Time frame: Up to three years
Objective response rate
Time frame: Up to two years
Disease control rate
Time frame: Up to two years
Adverse Events
Time frame: Up to two years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Apatinib and Pemetrexed in people with Advanced Non-squamous Non-small-cell Lung Cancer, run by Xinqiao Hospital of Chongqing at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival（PFS） (time frame: Up to two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.